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Ex-GSK General Counsel Acquitted By Judge Of Obstructing FDA Investigation

GREENBELT, Md. - (Mealey's) Former GlaxoSmithKline vice president and associate general counsel Lauren Stevens was acquitted by directed verdict May 10 of charges of obstructing a Food and Drug Administration investigation into the off-label promotion of the antidepressant drug Wellbutrin SR (United States of America v. Lauren Stevens, No. 8:10-cr-00694, D. Md.).

On the 10th day of trial, U.S. Judge Roger W. Titus of the District of Maryland granted Stevens' motion for acquittal. Judge Titus did not issue a written reason for granting the motion.

In November, Stevens was indicted by a grand jury on one count of obstruction of a proceeding, one count of falsification and concealment of documents and four counts of making false statements. The FDA was investigating a report that GSK promoted Wellbutrin for weight loss, an unapproved use.

On March 23, Judge Titus dismissed the indictment without prejudice after finding that a prosecutor gave a grand juror an erroneous answer about good faith reliance on legal advice and that that advice may have substantially influenced the vote to indict. Stevens was re-indicted on April 13.

The government alleged that Stevens was in charge of responding to the agency's request for materials related to Wellbutrin promotional programs sponsored by GSK. The government alleged that Stevens withheld and concealed documents and other information about Wellbutrin's promotion while telling the FDA that the company had completely responded to the agency's requests.

The government also alleged that Stevens falsified and altered documents to impede the FDA's investigation.

Withheld were slide sets used by speakers at GSK promotional events that promoted off-label use of Wellbutrin and information about compensation paid to event attendees, the government said. The government said Stevens signed six letters containing materially false statements.

The trial began April 26. Stevens moved for a judgment of acquittal after the government rested its case.

[Editor's Note: Full coverage will be in the May 19 issue of Mealey's Emerging Drugs & Devices. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]